From the Department of Neurology and Weill Institute for Neurosciences, University of California, CA.
Neurology. 2021 Apr 27;96(17):799-804. doi: 10.1212/WNL.0000000000011834. Epub 2021 Mar 16.
Neurostimulation provides a new dimension in the treatment of neurologic disorders. For patients with drug-resistant epilepsy, the Responsive Neurostimulation (RNS) System (NeuroPace, Inc.) provides treatment of seizures with a closed-loop device that continuously records brain activity and provides stimulation designed to reduce seizure frequency over time. The presence of a chronic implanted device that can provide an electrographic record of neural activity provides great opportunities for treatment of seizure disorders and neuroscience research. However, our experience with this device indicates that a number of ethical and clinical challenges arise, and these issues may be applicable to neurotechnology developed for other disease states in the future. We present clinical scenarios based on cases from our center that present clinical or ethical dilemmas. The dilemmas revolve around 4 core themes: (1) electroclinical correlation and dissociation; (2) patient concerns about device capabilities; (3) clinician opportunities and burdens; and (4) data ownership and access. Developing a framework for understanding these issues will be critical as closed-loop neuromodulation is applied to a growing range of neuropsychiatric disorders.
神经刺激为治疗神经系统疾病提供了一个新的维度。对于耐药性癫痫患者，反应性神经刺激 (RNS) 系统 (NeuroPace, Inc.) 提供了一种闭环设备的治疗，该设备可以持续记录大脑活动并提供刺激，旨在随着时间的推移减少癫痫发作的频率。存在一种可以提供神经活动电图记录的慢性植入设备，为治疗癫痫发作障碍和神经科学研究提供了巨大的机会。然而，我们使用该设备的经验表明，出现了许多伦理和临床挑战，这些问题可能适用于未来为其他疾病状态开发的神经技术。我们提出了基于我们中心的案例的临床情况，这些案例提出了临床或伦理困境。这些困境围绕着 4 个核心主题：(1) 电临床相关性和分离；(2) 患者对设备功能的关注；(3) 临床医生的机会和负担；以及 (4) 数据所有权和访问。随着闭环神经调节被应用于越来越多的神经精神障碍，为理解这些问题制定一个框架将是至关重要的。
